Dorbene vet 1 mg/ml solution for injection for dogs and cats

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Medetomidine hydrochloride

MAH:

Laboratorios SYVA, S.A.U

ATC_code:

QN05CM91

INN:

Medetomidine hydrochloride

dosage:

1 milligram(s)/millilitre

pharmaceutical_form:

Solution for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Cats, Dogs

therapeutic_area:

medetomidine

therapeutic_indication:

Neurological Preparations

authorization_status:

Authorised

authorization_date:

2012-03-02

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dorbene vet 1 mg/ml solution for injection for dogs and cats.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE:
Medetomidine hydrochloride
1.0 mg
(equivalent to 0.85 mg medetomidine)
EXCIPIENTS:
Methyl parahydroxybenzoate (E 218)
1.0 mg
Propyl parahydroxybenzoate (E 216)
0.2 mg
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_In dogs and cats:_
Sedation to facilitate handling. Premedication prior to general
anaesthesia.
_In cats:_
In combination with ketamine for general anaesthesia for minor
surgical procedures of short duration.
4.3 CONTRAINDICATIONS
Do not use in animals with:
- Severe cardiovascular disease or respiratory diseases or impaired
liver or kidney function.
- Mechanical disturbances of the gastro-intestinal tract (torsio
ventriculi, incarcerations,
oesophageal obstructions).
- Diabetes mellitus.
- State of shock, emaciation or serious debilitation.
Do not use concomitantly with sympathomimetic amines.
Do not use in cases of known hypersensitivity to the active substance
or to any other excipients.
Do not use in animals with ocular problems where an increase in
intraocular pressure would be detrimental.
See also section 4.7
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